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Relevant bibliographies by topics / Biopharmaceutical Drug Development

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Academic literature on the topic 'Biopharmaceutical Drug Development'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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Journal articles on the topic "Biopharmaceutical Drug Development"

1

Todorovic, Zoran, and Dragana Protic. "Bioethical issues in the development of biopharmaceuticals." Filozofija i drustvo 23, no. 4 (2012): 49–56. http://dx.doi.org/10.2298/fid1204049t.

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Development of biopharmaceuticals is a challenging issue in bioethics. Unlike conventional, small molecular weight drugs, biopharmaceuticals are proteins derived from DNA technology and hybrid techniques with complex three dimensional structures. Immunogenicity of biopharmaceuticals should always be tested in clinical settings due to low predictive value of preclinical animal models. However, non-human primates (NHP) and transgenic mice could be used to address certain aspects of immunogenicity. Substantial efforts have been made to reduce NHP use in biopharmaceutical drug development, e.g. st

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Lamborn, Kathleen R., and Karl E. Peace. "Biopharmaceutical Statistics for Drug Development." Journal of the American Statistical Association 84, no. 406 (1989): 629. http://dx.doi.org/10.2307/2289980.

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Hovgaard, Lars. "Biopharmaceutical Drug Design and Development." Journal of Controlled Release 66, no. 2-3 (2000): 323. http://dx.doi.org/10.1016/s0168-3659(99)00284-9.

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Legg, Lorna, and K. E. Peace. "Biopharmaceutical Statistics for Drug Development." Applied Statistics 39, no. 1 (1990): 137. http://dx.doi.org/10.2307/2347829.

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Jennings, Simon, and K. E. Peace. "Biopharmaceutical Statistics for Drug Development." Journal of the Royal Statistical Society. Series A (Statistics in Society) 156, no. 1 (1993): 136. http://dx.doi.org/10.2307/2982881.

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Metzler, Carl M. "Biopharmaceutical statistics for drug development." Journal of Pharmaceutical Sciences 77, no. 8 (1988): 733. http://dx.doi.org/10.1002/jps.2600770822.

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Cvijic, Sandra, Svetlana Ibric, and Jelena Parojcic. "Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application." Chemical Industry 74, no. 6 (2020): 389–97. http://dx.doi.org/10.2298/hemind210104002c.

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The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships between drug product quality attributes (in vitro data) and its clinical performance (in vivo data). In the present paper, contemporary biopharmaceutics toolkit including in vivo predictive dissolution testing, Biopharmaceutics Classification System, physiologically based pharmacokinetic and biopharmaceutics modeling and simulation, in vitro-in vivo correlati

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Bandaliyeva, A., S. Muslumzade, A. Huseynova, and M. Aslanov. "THE EFFECT OF THE PHYSICAL STATE OF THE SUBSTANCE ON THE THERAPEUTİC EFFİCACY OF DRUGS." Scientific heritage, no. 157 (March 25, 2025): 74–76. https://doi.org/10.5281/zenodo.15085530.

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In recent years, several directions of biopharmaceutical research have been identified in pharmacy: studying the role of pharmaceutical factors, absorption conditions, biotransformation, biological affinity and its determination methods, development of methods for identifying drugs in biological fluids, investigation of drug pharmacokinetics, and determination of clinical effects. One of the main objectives of biopharmaceutics is to study the physical state of substances, which plays a crucial role in the therapeutic significance of drugs. In the past, insufficient attention was given to the p

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Biopharmaceutical, Classification System dissolution permeability Gastrointestinal track ., and J. Bhor1 Rashid Azeez2 Vinod A. Bairagi3 Kalyani. "Review: Biopharmaceutical Classification System." International Journal in Pharmaceutical Sciences 2, no. 3 (2024): 350–66. https://doi.org/10.5281/zenodo.10810211.

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Dr. Gordon Amidon developed the Biopharmaceutical Classification System (BCS) to classify pharmacological compounds based on their solubility in water and intestinal permeability. His work in this area earned him the Science Award from the International Pharmaceutical Federation (FIP) in August 2006. The BCS has since been used by the U.S. Food and Drug Administration to estimate the absorption of oral medications in the intestines. It has become an indispensable tool in regulatory decision-making for drug development, allowing for the evaluation of dissolution, solubility, and intestinal perm

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Moscicki, Richard A., and P. K. Tandon. "Drug-Development Challenges for Small Biopharmaceutical Companies." New England Journal of Medicine 376, no. 5 (2017): 469–74. http://dx.doi.org/10.1056/nejmra1510070.

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Dissertations / Theses on the topic "Biopharmaceutical Drug Development"

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Rajapakse, Thiaga Anuradha. "Biopharmaceutical drug development modelling and portfolio management." Thesis, University College London (University of London), 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.413689.

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Faragalla, Jane Eliza. "Development of isoflavonoid-derived anti-prostatic cancer agents." Access electronically, 2005. http://www.library.uow.edu.au/adt-NWU/public/adt-NWU20060516.121728/index.html.

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Fung, Ho Ki. "Synthesis and development of manufacturing processes for biopharmaceuticals /." View Abstract or Full-Text, 2003. http://library.ust.hk/cgi/db/thesis.pl?BIEN%202003%20FUNG.

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Lindenberg, Marc. "A biopharmaceutics classification scheme for the development of new drugs." Aachen Shaker, 2007. http://d-nb.info/987761897/04.

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Lindenberg, Marc. "A biopharmaceutics classification scheme for the development of new drugs /." Aachen : Shaker, 2008. http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&doc_number=016726181&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA.

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Lindenberg, Marc [Verfasser]. "A biopharmaceutics classification scheme for the development of new drugs / Marc Lindenberg." Aachen : Shaker, 2008. http://d-nb.info/116434238X/34.

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Munday, Dale Leslie. "Design, development and evaluation of encapsulated oral controlled release theophylline mini-tablets." Thesis, Rhodes University, 1991. http://hdl.handle.net/10962/d1003255.

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Conventional solid dosage forms often lead to fluctuations which exceed the maximum safe therapeutic level and/or decline below the minimum effective level. It is recognised that many drugs for chronic administration should be administered on a schedule that maintains plasma drug concentration within the therapeutic window. Research in controlled release dosage forms aims at designing a system with a zero-order input (eg, ideally to deliver 8.33% of the dose per hour over a 12 hour duration), producing steady state plasma drug levels. Oral dministration of drugs prepared as a controlled releas

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Jede, Christian [Verfasser], Werner [Akademischer Betreuer] Weitschies, Werner [Gutachter] Weitschies, and Jennifer [Gutachter] Dressman. "Development of translational biopharmaceutical assays for biorelevant dissolution and precipitation testing of poorly soluble drugs / Christian Jede ; Gutachter: Werner Weitschies, Jennifer Dressman ; Betreuer: Werner Weitschies." Greifswald : Universität Greifswald, 2019. http://d-nb.info/120054773X/34.

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Jede, Christian [Verfasser], Werner Akademischer Betreuer] Weitschies, Werner [Gutachter] Weitschies, and Jennifer B. [Gutachter] [Dressman. "Development of translational biopharmaceutical assays for biorelevant dissolution and precipitation testing of poorly soluble drugs / Christian Jede ; Gutachter: Werner Weitschies, Jennifer Dressman ; Betreuer: Werner Weitschies." Greifswald : Universität Greifswald, 2019. http://d-nb.info/120054773X/34.

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Jede, Christian [Verfasser], Werner [Akademischer Betreuer] Weitschies, Werner Gutachter] Weitschies, and Jennifer B. [Gutachter] [Dressman. "Development of translational biopharmaceutical assays for biorelevant dissolution and precipitation testing of poorly soluble drugs / Christian Jede ; Gutachter: Werner Weitschies, Jennifer Dressman ; Betreuer: Werner Weitschies." Greifswald : Universität Greifswald, 2019. http://d-nb.info/120054773X/34.

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Books on the topic "Biopharmaceutical Drug Development"

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Susanna, Wu-Pong, and Rojanasakul Yongyut, eds. Biopharmaceutical drug design and development. 2nd ed. Humana Press, 2008.

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Wu-Pong, Susanna, and Yon Rojanasakul, eds. Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9.

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Wu-Pong, Susanna, and Yongyut Rojanasakul, eds. Biopharmaceutical Drug Design and Development. Humana Press, 1999. http://dx.doi.org/10.1007/978-1-59259-705-5.

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1941-, Peace Karl E., ed. Biopharmaceutical statistics for drug development. M. Dekker, 1988.

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5

Susanna, Wu-Pong, and Rojanasakul Yongyut, eds. Biopharmaceutical drug design and development. Humana Press, 1999.

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6

Jameel, Feroz, John W. Skoug, and Robert R. Nesbitt, eds. Development of Biopharmaceutical Drug-Device Products. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-31415-6.

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Khan, Mansoor A., Feroz Jameel, Susan Hershenson, and Sheryl Martin-Moe. Quality by design for biopharmaceutical drug product development. Springer, 2015.

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Jameel, Feroz, Susan Hershenson, Mansoor A. Khan, and Sheryl Martin-Moe, eds. Quality by Design for Biopharmaceutical Drug Product Development. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2316-8.

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1955-, Chow Shein-Chung, ed. Encyclopedia of biopharmaceutical statistics. 2nd ed. Marcel Dekker, 2003.

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10

Guedj, Ilan. Organizational scope and investment: Evidence from the drug development strategies and performance of biopharmaceutical firms. National Bureau of Economic Research, 2004.

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Book chapters on the topic "Biopharmaceutical Drug Development"

1

Azad, Neelam, and Yon Rojanasakul. "Macromolecular Drug Delivery." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_14.

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Kompella, Udaya B. "Protein Drug Delivery." In Biopharmaceutical Drug Design and Development. Humana Press, 1999. http://dx.doi.org/10.1007/978-1-59259-705-5_10.

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Lanfear, Denny, Randy Hassler, Karen Sitney, et al. "Protein Drug Manufacturing." In Biopharmaceutical Drug Design and Development. Humana Press, 1999. http://dx.doi.org/10.1007/978-1-59259-705-5_11.

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Haining, Robert L. "Pharmacogenetic Issues in Biopharmaceutical Drug Development." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_6.

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Foote, Mary Ann, and Thomas Boone. "Biopharmaceutical Drug Development: A Case History." In Biopharmaceuticals, an Industrial Perspective. Springer Netherlands, 1999. http://dx.doi.org/10.1007/978-94-017-0926-2_4.

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Fillmore, Helen L., and Susanna Wu-Pong. "Stem Cell Technology and Drug Development." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_9.

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Hale, Victoria G. "Product Development and New Drug Approval." In Biopharmaceutical Drug Design and Development. Humana Press, 1999. http://dx.doi.org/10.1007/978-1-59259-705-5_14.

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Wu-Pong, Susanna. "Biotechnology: 2008 and Beyond." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_1.

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Zhang, A. Yin, and Susanna Wu-Pong. "Small Nucleic Acid-Based Drugs: Successes and Pitfalls." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_10.

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Tam, Robert C., Zhi Hong, Miriana Moran, Andrei Varnavski, and Sung-Kwon Kim. "Therapeutic Strategies Targeting the Innate Antiviral Immune Response." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_11.

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Conference papers on the topic "Biopharmaceutical Drug Development"

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Sarkis, Miriam, Steven Sachio, Nilay Shah, Cleo Kontoravdi, and Maria M. Papathanasiou. "Towards 3-fold sustainability in biopharmaceutical process development and product distribution." In Foundations of Computer-Aided Process Design. PSE Press, 2024. http://dx.doi.org/10.69997/sct.141233.

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The (bio-)pharmaceutical industry is facing crossroads in an effort to ramp up its global capacity, while working to meet net-zero targets and to ensure continuous drug supply. Beyond geopolitical challenges faced worldwide, (bio-)pharmaceutical processes have been historically very complex to design, optimise and integrate in a global distribution network that is resilient and adaptable to changes. In this paper we offer a perspective of how Process Systems Engineering (PSE) tools can support and advance (bio-)pharma practices with an outlook towards 3-fold sustainability. The latter is consi

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SKERRA, ARNE. "ANTICALINS® & PASYLATION®: NEW CONCEPTS FOR BIOPHARMACEUTICAL DRUG DEVELOPMENT FROM PROTEIN DESIGN." In 23rd International Solvay Conference on Chemistry. WORLD SCIENTIFIC, 2014. http://dx.doi.org/10.1142/9789814603836_0034.

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Buddhadev, Sheetal, and Kevin Garala. "Self-Nano Emulsifying Drug-Delivery Systems: From the Development to The Current Applications and Update of the Biopharmaceutical Aspect." In 1st International Electronic Conference on Biomedicine. MDPI, 2021. http://dx.doi.org/10.3390/ecb2021-10296.

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Khalikov, S. S. "FEATURES OF MECHANOCHEMICAL TECHNOLOGY IN THE DEVELOPMENT OF PARASITOCIDES." In THEORY AND PRACTICE OF PARASITIC DISEASE CONTROL. All-Russian Scientific Research Institute for Fundamental and Applied Parasitology of Animals and Plant – a branch of the Federal State Budget Scientific Institution “Federal Scientific Centre VIEV”, 2023. http://dx.doi.org/10.31016/978-5-6048555-6-0.2023.24.498-502.

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The purpose of the research is to study the features of the mechanochemical modification of medicinal substances with low solubility in water. According to the Biopharmaceutics Classification System, about 6% of medicinal substances belong to the group of insoluble medicinal substances, and about 47%, to practically insoluble medicinal substances, i.e. more than a half substances have problems with solubility, and therefore bioavailability and pharmacological activity. To achieve the therapeutic effect of such substances, it is necessary to deliberately incr

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Vlada, Marin. "NONLINEAR MODELS. THEORY, SOFTWARE AND APPLICATIONS." In eLSE 2013. Carol I National Defence University Publishing House, 2013. http://dx.doi.org/10.12753/2066-026x-13-188.

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This paper presents mathematical models that estimate nonlinear evolution processes or phenomena based on parameters that define processes and phenomena in pursuit of calculations and approximations (fitting) of experimental data. It addresses the non-linear model (nonlinear regression), the method of Least Squares (MLS) with examples. Are presented theoretical calculations for logarithmic and exponential models realizing a comparison with results obtained using software. In practice in various scientific, economic, social, etc.. occur most complex problems to be solved. Science and scientific

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Reports on the topic "Biopharmaceutical Drug Development"

1

Guedj, Ilan, and David Scharfstein. Organizational Scope and Investment: Evidence from the Drug Development Strategies and Performance of Biopharmaceutical Firms. National Bureau of Economic Research, 2004. http://dx.doi.org/10.3386/w10933.

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FDG-PET/CT SUV for Response to Cancer Therapy, Clinically Feasible Profile. Chair Nathan Hall and Jeffrey Yap. Radiological Society of North America (RSNA) / Quantitative Imaging Biomarkers Alliance (QIBA), 2023. http://dx.doi.org/10.1148/qiba/20230615.

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This QIBA Profile documents specifications and requirements to provide comparability and consistency for quantitative FDG-PET across scanners in oncology. It can be applied to both clinical trial use as well as individual patient management. This document organizes acquisition, reconstruction and post-processing, analysis and interpretation as steps in a pipeline that transforms data to information to knowledge. The document, developed through the efforts of the QIBA FDG-PET Biomarker Committee, has shared content with the FDG-PET UPICT protocol, as well as additional material focused on the d

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Evidence Synthesis and Meta-Analysis for Drug Safety. Council for International Organizations of Medical Sciences (CIOMS), 2016. http://dx.doi.org/10.56759/lela7055.

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At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. -- There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to hav

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